Titanium tetrakis(dimethylammonium)

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

review article or handbook

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Dimethylamine

EC Number:

204-697-4

EC Name:

Dimethylamine

Cas Number:

124-40-3

Molecular formula:

C2H7N

IUPAC Name:

N-methylmethanamine

Test material form:

liquid

Details on test material:

supplier: Eastman

Specific details on test material used for the study:

supplier: Eastman
purity: vendor purity no further information given

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Details on mammalian cell type (if applicable):

not applicable

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9 fractions of Acrolor 1254-induced male Sprague-Dawley rat livers and male Syrian hamster livers were prepared. The S9 mixes were prepared immediately prior to use and contained 10% S9

Test concentrations with justification for top dose:

first test: 0; 33; 100; 333; 1000; 2000; 3333; 4500 µg/plate
second test: 0; 100; 333; 1000; 2000; 3333; 4000 µg/plate

Vehicle / solvent:

distilled water

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

other: 4-nitro-o-phenylenediamine: without metabolic activation, strain TA98; 2-aminoanthracene: with metabolic activation, all strains tested

Details on test system and experimental conditions:

prior to the main test a toxicity assay was carried out with strain TA 100 to determine the appropriate dose range
seven doses were tested in triplicate, experiment was repeated one week after the initial trial

Evaluation criteria:

A chemical was judged to be mutagenic (+) or weakly mutagenic (+W) if it produce a reproducible, doese related increase in his+ over the corresponding solvent control in replicate trials. A chemical was considered questionable if a reproducible increase in his+revertants did not meet the criteria of either a "+" or"+W" or if only a single doses produced an increase in his+ revertants in repeat trials

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

other: not mutagenic

Applicant's summary and conclusion

Executive summary:

Dimethylamine did not show any mutagenic potential both with and without metabolic activation in an in vitro bacterial gene mutation study according to OECD TG 471.